Manufacturing and Purification

XYNTHA was designed with viral safety in mind1,2

Albumin-free

XYNTHA is completely albumin-free from the start. An albumin-free cell culture contains recombinant insulin, with no materials derived from human or additional animal sources.*

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Initial purification

XYNTHA goes through a purification process designed with viral safety in mind to help remove any unwanted materials, including potential viruses.*

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Synthetic ligand

XYNTHA uses a synthetic ligand instead of animal-derived molecules. The manufacturing and purification process is designed to reduce the risk of viral contamination.

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Nanofiltration

XYNTHA utilizes a 35-nanometer, pore-sized filter to further eliminate contaminants and reduce the chance of viral contamination.

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Manufacturing and purification

Watch the video for more information about how XYNTHA is made.​​​​​​​​​​​​​​
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  *The chemically defined cell culture medium in which the Chinese hamster ovary (CHO) cells are grown contains recombinant insulin but does not contain any materials derived from human or added animal sources.

   †Non–factor VIII process-related components (NPRC) such as proteins, nutrients, and salts.

   ‡This medium contains NPRC such as proteins, nutrients, and salts.
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Potency and monitoring​​​​​​​

  • Manufacturing reference standard calibrated against the World Health Organization (WHO) 7th International Standard for factor VIII activity using the one-stage clotting assay
  • The potency expressed in International Units (IU) is determined using the chromogenic assay of the European Pharmacopoeia
  • Clinically monitored using the one-stage clotting assay

When clinically indicated, patients should have plasma factor VIII activity levels monitored by the one-stage clotting assay to confirm that adequate factor VIII levels have been achieved and are maintained.
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References:
  1. XYNTHA SOLOFUSE. Prescribing information. Pfizer Inc.; 2020. 
  2. Kelley B, Jankowski M, Booth J. An improved manufacturing process for Xyntha/ReFacto AF. Haemophilia. 2010;16(5):717-725. doi:10.1111/j.1365-2516.2009.02160.x

Dosing

  • Dosing With All-In-One Reconstitution
  • Manufacturing and Purification
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Proven Bleed Control

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Low Rate of Inhibitors

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Pediatric Indication

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  • Do not use in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster proteins.
  • Allergic-type hypersensitivity reactions, including anaphylaxis, are possible with XYNTHA. Inform patients of the early signs or symptoms of hypersensitivity reactions (including hives, generalized urticaria, chest tightness, wheezing, and hypotension) and anaphylaxis. Discontinue XYNTHA if hypersensitivity symptoms occur and administer appropriate emergency treatment. XYNTHA contains trace amounts of hamster proteins. Patients may develop hypersensitivity to these proteins.
  • Inhibitors have been reported following administration of XYNTHA. Monitor patients for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests.
  • Clinical response to XYNTHA may vary. If bleeding is not controlled with the recommended dose of factor, determine the plasma level and administer a dose of XYNTHA sufficient to achieve clinical response. If the factor level does not increase or there is no response, suspect an inhibitor and perform appropriate testing.
  • Across all studies, the most common adverse reactions (≥10%) with XYNTHA in previously treated adult and pediatric patients were headache (24% of subjects), arthralgia (23%), fever (23%), and cough (12%). Other adverse reactions reported in ≥5% of subjects were diarrhea, vomiting, and weakness.
  • XYNTHA is an injectable medicine administered by intravenous (IV) infusion. Patients should be advised that local irritation may occur when infusing XYNTHA after reconstitution in XYNTHA® SOLOFUSE®.

XYNTHA® Antihemophilic Factor (Recombinant) is indicated in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, for perioperative management, and for routine prophylaxis to reduce the frequency of bleeding episodes. 

XYNTHA is not indicated in patients with von Willebrand’s disease. 

Please see full Prescribing Information for XYNTHA and XYNTHA SOLOFUSE.

Indication

XYNTHA® Antihemophilic Factor (Recombinant) is indicated in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, for perioperative management, and for routine prophylaxis to reduce the frequency of bleeding episodes. 

XYNTHA is not indicated in patients with von Willebrand’s disease. 

Please see full Prescribing Information for XYNTHA and XYNTHA SOLOFUSE.